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NeuroDerm Announces Positive Results of a Phase II Study of ND0611 Dermal Patch in Patients with Parkinson’s Disease

November 9, 2011

NESS ZIONA, Israel, November 9, 2011 /PRNewswire/ –

NeuroDerm [http://www.neuroderm.com ], Ltd. announced today the results
of a Phase I/II safety and pharmacokinetic trial of ND0611, administered as
an adjunct therapy to Sinemet(R), Sinemet(R) CR or Stalevo(R), in patients
with advanced Parkinson’s disease. ND0611 is a proprietary carbidopa liquid
formula administered sub-cutaneously via a dermal patch to increase the
bioavailability and efficacy of orally- administered levodopa. Results of
this study support the continued development of ND0611 for the treatment of
Parkinson’s disease.

This double-blind, randomized, six-way crossover study met all of its
primary and secondary endpoints. The analysis showed that ND0611, when
compared with placebo, showed meaningful, highly statistically significant
improvement in all of the pharmacokinetic (PK) endpoints when administered
with three most common oral levodopa therapies (immediate-release
Sinemet(R), Sinemet(R)-CR, and Stalevo(R)). The primary and secondary PK
endpoints included levodopa half-life, the duration of levodopa
concentration in excess of a threshold of 1000ng/ml in plasma, the
area-under-the-concentration-time-curve and levodopa trough levels. The full
results of this study will be presented at a future scientific meeting.

The most common adverse events across all treatment arms, including
placebo, were vertigo, nausea, asthenia, back pain, myalgia, pain in
extremity, headache and erythema. There were no clinically relevant effects
seen in laboratory measured or vital signs.

“This first trial in patients of ND0611 hit all of its endpoints and was
a complete success. ND0611 is an innovative treatment for PD and this
important milestone justifies ND0611′s further clinical and regulatory
development,” said Sheila Oren, MD, VP Clinical and Regulatory Affairs at
NeuroDerm.

“One of our priorities at MJFF is to drive research that could improve
the quality of life for people living with PD today,” said Brian Fiske, PhD,
director of research programs at MJFF. “NeuroDerm is working to develop a
therapy that might do just that. By providing a more even and continuous
supply of levodopa to the brain, ND0611 has the potential to limit the motor
fluctuations that many patients experience during periods when their
medication wears off.”

“ND0611′s remarkable success in its first phase I/II trial significantly
raises the probability of it becoming a new treatment option for PD
patients. ND0611 is unique: it is the first drug developed to administer
carbidopa systemically; it acts directly on levodopa metabolism not only in
the gastrointestinal tract; and it probably employs a different mode of
action than orally administered carbidopa,” said Oded S. Lieberman, PhD,
NeuroDerm’s Chairman and CEO. “ND0611 has now been shown to improve
levodopa’s bioavailability in patients with any type of oral levodopa drug
used even improving the bioavailability of what is considered to be the best
current levodopa oral therapy. One can now realistically hope that ND0611
may eventually establish a higher standard of care for PD patients
undergoing oral LD therapy”.

About the phase I/II Safety and Pharmacokinetic Study

This placebo controlled, randomized, double-blind, six-way crossover
trial enrolled 24 patients with advanced Parkinson’s disease. All patients
were administered the three most commonly-used levodopa therapies
(immediate-release Sinemet(R), Sinemet(R)-CR, and Stalevo(R)) in 100mg
dosage four times per day; in addition they received either ND0611 or
placebo.

In addition to evaluating safety and tolerability, the study’s primary
endpoint was improvement in levodopa half life in all treatment arms;
secondary endpoints included additional PK parameters. All PK parameters for
each oral treatment mode were evaluated separately and showed statistical
significance.

This trial was supported by a grant of $1 million by The Michael J. Fox
Foundation for Parkinson’s Research as part of the Foundation’s Clinical
Intervention Awards 2010 program.

About Parkinson’s Disease

Parkinson’s disease affects approximately 6 million patients in the
world. It is caused by decreasing dopamine signaling in the brain as
dopaminergic brain cells die off. Levodopa is the “Gold Standard” therapy
for Parkinson’s disease, and virtually all patients receive it. Levodopa is
always co-administered with a degradation inhibitor (usually, carbidopa).
When administered through the oral route, however, levodopa suffers from a
short clearance half-life and low bioavailability that contributes to motor
complications in Parkinson’s patients.

About ND0611

ND0611 is based on a proprietary formulation that enables, for the first
time, the continuous administration of carbidopa in a practical manner via a
subcutaneous dermal patch. Carbidopa, conventionally co-administered with
levodopa orally to prevent its breakdown, suffers from low bioavailability
in itself. Continuous subcutaneous delivery of carbidopa should thus improve
the bioavailability of oral levodopa, permit more continuous levels of
levodopa to be maintained in the brain, improve the management of motor
fluctuations in Parkinson’s disease patients and result in a more
efficacious usage of levodopa in Parkinson’s disease therapy.

About NeuroDerm

NeuroDerm is an emerging pharmaceutical company that develops therapies
for the treatment of CNS diseases. NeuroDerm’s technology is based on
proprietary reformulations of well established oral drugs whose low
bio-availability is the major impediment to better efficacy. The company’s
lead products are ND0611, a revolutionary skin patch for the treatment of
Parkinson’s disease and ND0801, a combination patch for the treatment of
ADD/ADHD. Other programs focused at other diseases, including schizophrenia
and Alzheimer’s disease, are in different stages of development. NeuroDerm
is headquartered in the Weizmann Science Park, Ness Ziona, Israel.

About The Michael J. Fox Foundation for Parkinson’s Research

As the world’s largest private funder of Parkinson’s research, The
Michael J. Fox Foundation is dedicated to accelerating a cure for
Parkinson’s disease and improved therapies for those living with the
condition today. The Foundation pursues its goals through an aggressively
funded, highly targeted research program coupled with active global
engagement of scientists, Parkinson’s patients, business leaders, clinical
trial participants, donors and volunteers. In addition to funding more than
$270 million in research to date, the Foundation has fundamentally altered
the trajectory of progress toward a cure. Operating at the hub of worldwide
Parkinson’s research, the Foundation forges groundbreaking collaborations
with industry leaders, academic scientists and government research funders;
increases the flow of participants into Parkinson’s disease clinical trials
with its online tool, Fox Trial Finder; promotes Parkinson’s awareness
through high-profile advocacy, events and outreach; and coordinates the
grassroots involvement of thousands of Team Fox members around the world.
Now through December 31, 2012, all new and increased giving to The Michael
J. Fox Foundation, as well as gifts from donors who have not given since
2009 or earlier, will be matched on a dollar-for-dollar basis with the
$50-million Brin Wojcicki Challenge, launched by Sergey Brin and Anne
Wojcicki.

For more information visit:

http://www.michaeljfox.org ;

http://www.facebook.com/michaeljfoxfoundation.

        Contact:
        Oded S. Lieberman, PhD MBA, Chairman & CEO
        oded@neuroderm.com
        Tel.: +972-8-946-2729; Cell: +1-617-517-6077

SOURCE NeuroDerm Ltd


Source: PR Newswire